Hologic, Inc. Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
Brand
Hologic, Inc.
Lot Codes / Batch Numbers
Software Version: SFW-00700, Rev-002
Products Sold
Software Version: SFW-00700, Rev-002
Hologic, Inc. is recalling Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software due to Software error may lead to a high estimate of major fracture probability.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software error may lead to a high estimate of major fracture probability.
Recommended Action
Per FDA guidance
Hologic notified customers by telephone on 9/23 and 24/08 and instructed them to not use the software. A customer notification letter was sent via FedEx to customers on September 25, 2008.The letter requested de-installation of the software and return of the software to Hologic in a pre-paid envelope.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026